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| Descriptive Information Fields | |||||
| Brief Title † | Effectiveness of a Normalization of Eating Intervention Program for Treating Women With Eating Disorders | ||||
| Official Title † | Adaptation of a CBT Intervention for Eating Disorders | ||||
| Brief Summary | This study will evaluate the effectiveness of a new approach to a normalization of eating program, based on principles of cognitive-behavioral therapy, in treating women with anorexia nervosa or bulimia nervosa. |
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| Detailed Description | Eating disorders are real, treatable medical illnesses. They are often characterized by disturbances in eating behavior, such as drastic reduction of food intake or extreme overeating, as well as feelings of distress or extreme concern about body shape or weight. The two main types of eating disorders are anorexia nervosa and bulimia nervosa. A third type, binge-eating disorder, is pending approval as a formal psychiatric diagnosis. Eating disorders frequently develop during adolescence or early adulthood, and they occur more often in females than in males. Studies have shown cognitive behavioral therapy (CBT) to be the most effective approach to treating eating disorders. However, the applicability of these findings to clinical settings and intensive outpatient therapy programs (IOPs) remains unknown. This study will evaluate the effectiveness of a new approach to a normalization of eating (NOE) program, based on principles of CBT, in treating women with anorexia nervosa or bulimia nervosa. Participants in this open-label study will be assigned to receive either treatment-as-usual (TAU) or NOE. Participants admitted to the study in the first 8 months of the trial will receive TAU. Those admitted after the first 8 months will take part in the NOE program. Participants may begin receiving treatment as soon as they enter the study and will continue receiving their assigned treatments for 6 weeks. All participants in the NOE group will be required to report to the study site three evenings a week. They will receive individual therapy, as well as take part in group and family therapy sessions. In addition, they will be supervised while eating a meal. Body weight, results of the Eating Disorders Examination and the Structured Clinical Interview for DSM-IV Axis I disorders, and self-report measures will be assessed post-treatment and at the Month 6 follow-up visit. Note: Participants are recruited from the Renfrew Center's outpatient programs located in the Philadelphia area. Individuals outside of Renfrew cannot volunteer for this study. For more information about the Renfrew Center's inpatient or outpatient treatment programs, please call 1-800-RENFREW. |
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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Body weight [ Time Frame: Measured at baseline, discharge, and 6 month follow-up ] [ Designated as safety issue: No ] Structured Clinical Interview [ Time Frame: Measured at baseline ] [ Designated as safety issue: No ] Self-report [ Time Frame: Measured at baseline, discharge, and 6 month follow-up ] [ Designated as safety issue: No ] Eating Disorders Examination [ Time Frame: Measured at baseline, discharge, and 6 month follow-up ] [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | |||||
| Condition † | Eating Disorders | ||||
| Intervention † | Behavioral: Normalization of Eating (NOE) Behavioral: Treatment As Usual (TAU) |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 280 | ||||
| Start Date † | January 2006 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 15 Years to 40 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00272545 | ||||
| Organization ID | R34 MH71691 | ||||
| Secondary IDs †† | DATR A2-AIR | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | February 2008 | ||||
| First Received Date † | January 4, 2006 | ||||
| Last Updated Date | February 28, 2008 | ||||
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